Department of Justice Issues Positive Business Review Letter to Companies Developing Plasma Therapies for Covid-19
The Department of Justice announced today that it has no intention to challenge proposed efforts by Baxalta US Inc., Emergent BioSolutions Inc., Grifols Therapeutics LLC, and CSL Plasma Inc. (together, the “Requesting Parties”) to assist the Biomedical Advanced Research and Development Authority (BARDA) in designing quality standards for collecting COVID-19 convalescent plasma.
“This public-private collaboration will support innovation to develop life-saving medicines to treat COVID-19,” said Assistant Attorney General Makan Delrahim of the Justice Department’s Antitrust Division. “The department continues to stand ready to advise and assist whenever businesses meeting the exigent challenges of the pandemic face complex questions of antitrust law.”
As the department’s business review letter explains, convalescent plasma is taken from individuals who have had and recovered from COVID-19. The convalescent plasma can be given to patients directly, through infusion, or used to make hyperimmune globulin (HIg) therapies. The Requesting Parties aim to assist BARDA in the development of quality assurance parameters so that COVID-19 convalescent plasma collected by blood banks for direct transfusion under Project Warp Speed can be repurposed for use in the development and manufacture of each Party’s HIg therapies targeting COVID-19. The department believes these efforts are procompetitive to the extent that they will facilitate the more efficacious deployment of critical therapies for COVID-19, which could, in turn, improve the health and safety of Americans. The Requesting Parties have also put in place safeguards that minimize the risk their conduct will lessen competition.
This is the sixth expedited COVID-19 business review letter issued by the department since the department and the Federal Trade Commission first set out an expedited, temporary review procedure in the Joint Antitrust Statement Regarding COVID-19 (the “Joint Statement”). In April 2020, the department issued expedited business review letters to certain distributors of personal protective equipment (PPE) as well as the pharmaceuticals distributor AmerisourceBergen. Over the next several months, the department issued additional expedited business review letters to the National Pork Producers Council, certain manufacturers of monoclonal antibodies for use in COVID-19 vaccines and therapies, and a voluntary membership association of beauty salons.
Copies of the business review request and the department’s response are available on the Antitrust Division’s website at https://www.justice.gov/atr/business-review-letters-and-request-letters, as well as in a file maintained by the Antitrust Documents Group of the Antitrust Division. After a 30-day waiting period, any documents supporting the business review will be added to the file, unless a basis for their exclusion for reasons of confidentiality has been established under the business review procedure. Supporting documents in the file will be maintained for a period of one year, and copies will be available upon request to the FOIA/Privacy Act Unit, Antitrust Documents Group at firstname.lastname@example.org.